1. The Field of the Invention
The present invention relates to blinding tubes for clinical testing and related methods of assembly.
2. The Relevant Technology
An increasing number of pharmaceutical drugs are disposed in tubes and dispensed therefrom during use. Clinical trials for such tube-disposed pharmaceutical drugs require that the drug dosage be delivered in a blinded study. As part of the clinical trial protocols, outer markings can be removed from the tube or covered prior to administering the drug dosage. For instance, adhesive product labels can be peeled from the exterior of the tube leaving only the tubular container in which the drug dosage is disposed. Alternatively, the drug-containing tube can be wrapped in blinding tape or other material to cover the label or markings. Accordingly, the drug administering technician or recipient are blind as to the identity of the drug, the concentration thereof, or other characteristic being studied that may be reported on the label. The technician or recipient then simply dispenses the drug dosage from the covered tube.
In some cases, the tube includes identifying characteristics other than the written label. For instance, various tubes have unique shapes, sizes, colors, spouts, and other distinguishing features. The technician or recipient may not be blind as to these features by simply removing or covering the label of the tube. In particular, when comparing two different drugs, even slight differences between the tubes can lead the technician or recipient to believe that the respective drugs disposed therein are different. Controlling such perceived differences can be vital to the efficacy and fidelity of the clinical trial.
One way to overcome the appearance of these and other distinguishing features is to first dispense the drug dosage from the original tube into a standard, unmarked tube. All compared drugs in the trial are similarly squeezed from their sealed, manufacture tube into identical blinding tubes prior to proceeding with the trial. The drug can then be dispersed from the blinding tube, substantially preventing identification by the patient or technician. However, such transferring of a drug dosage can introduce a variety of variables that the clinical trial protocols seek to avoid. For instance, contamination, dosage alterations, and other undesirable consequences can result from squeezing the drug dosage from the first tube into the blinding tube prior to use. In addition, drug transfer can be costly, time-consuming, and annoying for drug administers.
Accordingly, what is needed in the art are blinding tubes and assemblies that overcome all or some of the above shortcomings.